Securing Urban Water Supply and Treatment Facilities

By: Dana H

Securing Urban Water Supply and Treatment Facilities A laboratory information management system can provide secure interoperability between laboratories and governing bodies

In the United States, with 55,000 water systems in place, the possibility of a coordinated disturbance in water sources is remote. However, the vulnerability of local treatment and supply infrastructure remains high, especially those supplying water to large metropolitan areas. Urban water supply and treatment facilities are exposed to increased risks of contamination and disruption and need attention to secure them. This multi-faceted challenge requires an effective strategy to address aspects from water supply infrastructure to information technology. The strategy must allow the exchange of information in a way that makes critical decisions expeditious.

The U.S. Environmental Protection Agency (EPA), a federal agency working with water utilities, enforces regulatory compliance under the Safe Drinking Water Act
(SDWA). This Act remained without specific requirements to address security and scrutiny of water supplies until it was amended by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. In March of this year, President Bush announced a program to better monitor urban water systems to detect contamination as quickly as possible and revealed intentions to increase appropriate budgets by 70 percent.

Many public health labs are deploying modern laboratory information management systems (LIMS) within the framework of the Public Health Information Network (PHIN) that support communications between labs in federal, state and local health departments and the healthcare community, using common messaging interfaces known as Health Level Seven (HL7) with Logical Observation Identifiers Names and Codes (LOINC) and Systematized Nomenclature of Medicine (SNOMED) as the common vocabulary for test names and observations. The importance of a unified framework is critical to better monitor these data streams for early detection of public health issues and emergencies, including bio-terrorism. Through structured data and vocabulary standards, collaborative approaches by PHIN will enable the consistent exchange of response, health and disease-tracking data between public health partners.

Side-by-side with the escalation of public health concerns, the issue of drinking water safety has led to increased testing and reporting requirements well beyond traditional levels. A LIMS system at an urban water lab functions as the central nerve center of the laboratory, managing and controlling all aspects of laboratory operations, quality assurance and management. Without a comprehensive LIMS, no modern laboratory can efficiently ensure compliance with regulatory requirements and simultaneously manage operations.

In an attempt to address complaints from the laboratory community regarding the burden of multiple accreditations due to the lack of a nationally recognized environmental laboratory accreditation program, the EPA initiated the National Environmental Laboratory Accreditation Conference (NELAC). NELAC was charged with establishing and promoting mutually acceptable performance standards for the inspection and operation of environmental laboratories. These standards are primarily designed around two International Organization for Standardization (ISO) guidance documents: ISO/International Engineering Consortium (IEC) Guide 25-1990: "General Requirements for the Competence of Calibration and Testing Laboratories," and ISO/IEC Guide 58: "Calibration and Testing Laboratory Accreditation Systems-General Requirements for Operation and Recognition."

Through its involvement in multiple public health initiatives, as well as water laboratory LIMS projects, STARLIMS Corp. has incorporated extensive reporting, surveillance and networking capabilities within a LIMS suite designed to fully support the daily functions of a multidisciplinary water laboratory in accordance with internationally accepted standards. Following is a summary of common requirements of urban water testing labs illustrated with selected examples drawn from STARLIMS.

&bull Remote sample login and results
Urban water labs serve customers outside the walls of the laboratory. Current Web-based technology allows remote lab customers to view analytical services provided by the laboratory via the Internet. Customers who submit samples for testing may review tests and price lists before ordering the service, pre-login their samples, view samples status and print reports. Submitters can print barcode labels locally and track sample package delivery and each sample's status. When results are published, the LIMS can provide visual notification to the submitters who can download and print the reports locally.

&bull Remote results entry
Field computers, including PDAs, are interfaced with the main LIMS database through various methods, including the exchange of Microsoft Excel files. For example, STARLIMS exports a sample's test information into an Excel file which is transferred to field computers. The file can include data validation checks and other error-trapping tools. When the operator returns, the LIMS processes the Excel file and extracts data into the database.

&bull Proactive communications
Improving communications within a laboratory and between laboratories is crucial to communicate exceptions and violations in a timely fashion. This can be accomplished with workflow-based notifications using e-mails and paging devices, including cell phones. In the case of STARLIMS, a Proactive Console is provided as a reminder and warning detection system. This allows users to intuitively navigate through the application and also to quickly identify tasks that need attention, such as approving results, calibrating or maintaining instruments and releasing a sample.

&bull Integrated document management
Maintaining version control for certificate of analysis (COA), standard operating procedure (SOP) and material safety data sheet (MSDS)-type documents, and their associations with test methods in use at the time the actual testing was conducted on samples is essential. This can be accomplished through tools for capturing, storing, retrieving, parsing and routing the relevant information to the appropriate decision makers.

&bull Security
It is crucial to secure vital laboratory data by limiting access to functionality and information. This includes support for security requirements consistent with good automated library practices (GALP), FDA's 21 CFR Part 11 and 40 CFR Part 3 and NELAC.

&bull Chain-of-custody
Maintaining a complete log of events related to each sample is also important. User-configurable chain-of-custody functions may be offered out-of-the-box, and logical functions can transfer samples based on system status and workflow settings. For example, STARLIMS provides
&bull history on status of containers
&bull history on samples
&bull history on contents locations
&bull history on the disposal of samples
&bull the genealogy of splits and aliquots
&bull user-configurable sample numbering schemes.

&bull Instrument maintenance
Ensuring maintenance and calibration of instruments is essential in meeting the lab's compliance with quality standards. Instrument information includes maintenance and calibration data, identification of tests that can be run on each instrument and the setup of quality control (QC) templates for each. This allows for the management of
&bull basic asset information
&bullservice contracts
&bull maintenance intervals
&bull registration of components
&bull responsible teams
&bull maintenance event tickets
&bull standards and QC templates
&bull data capture scripts and the XML schema that may be used to parse data.

&bull Quality control samples
Water testing laboratories generally require comprehensive tools for managing QC samples. These include life cycle; assignment to analytical processes; and integration of result entry operations along with associated analytical samples and the evaluation of their results against specifications for each analyte in the context of the test, test plan and project. STARLIMS provides a simple interface for batching samples together into a run and allows users to establish QC templates to automate placement of QC samples. Control charts are produced with integrated Northwest Analytical (NWA) QAx ActiveX controls.

&bull Automated results entry
Another common requirement is maintenance of result entry business rules, such as specifications evaluation and calculations, and applying them to manual and instrument data entry. Automated results entry and instrument interfacing can be achieved through a range of options including
&bull parsing of instrument output files using a data capture utility
&bull APIs published by instrument control software
&bull certified interfaces
&bull direct RS-232 connections
&bull XML parsing via Web services
Automation of results entry reduces the workload and eliminates transcription errors.

&bull Interoperability
The major part of today's IT budgets is dedicated to solving integration issues. At the heart of many implementations is interoperability between LIMS and other key business applications. Data generated by the water laboratory is essential for decision making by other groups of the organization that employ process control systems, or even Web portals. The functional benefits of this integration include real-time updating of specifications or procedures, rapid identification of process problems and automated logging of process control analyses.

&bull Traceability
Maintaining an audit trail of who, what, when, how and why is important to demonstrate traceability. In the case of STARLIMS, the auditor is allowed to view
&bull staff certification information
&bull instrument maintenance and calibrations
&bull QC data
&bull audit trails
Steps involved in creating the defendable result are documented by maintaining versions of
&bull test methods
&bull certifications
&bull log of instrument maintenance
&bull standards and control charts
&bull material management
&bull storage conditions
&bull chain of custody
&bull reporting templates
&bull outsourcing of lab services

&bull Reports and queries
Trend analysis, proficiency testing, turn around times, laboratory resource planning, and QC charting are just a few examples of common reports. These reports can be specific to the user, role, instrument, group, laboratory or location. Reports can be sent to a screen, printer, fax, or e-mailed or published to the intranet.

&bull Effective implementations
Each lab has individual requirements that need to be accounted for during implementation. These include
&bull incorporating existing test workflows
&bull instrument interfacing for automated run scheduling and data collection
&bull site-specific reporting
&bull interfacing the LIMS with other internal or external business systems.
While the STARLIMS platform provides enriched functionality for rapid deployment of common business processes, each organization has individual characteristics that are configured, validated and tested through an iterative site-specific implementation process. The implementation follows industry best practices as defined by the Project Management Institute's 'Project Management Body of Knowledge' (PMBOK 2000) and the International Society for Pharmacoepidemiology (ISPE)'s Good Automated Manufacturing Process (GAMP4) guide for validation of automated systems.

&bull Future proofing
Architecture can be designed to adapt to continuous change in regulations, local business requirements and IT, eliminating the need for large periodic re-investments and loss of content experienced during major upgrades. Complete separation of the technology components from the business rule elements and from the data sources, enables total partition of ongoing development and maintenance tasks, which makes it easier to configure new requirements and to validate, certify and maintain the system throughout the LIMS life cycle.
Conclusion
U.S. water supplies face barriers between silos of information with technology gaps creating risks that cannot be mitigated merely with physical surveillance and premise monitoring. Establishing secure and seamless interoperability between laboratories and governing bodies with harmonized standards and protocols for exchanging data via a LIMS can overcome many of these gaps. Today's highly flexible and full-featured commercial LIMS can provide complete traceability leading to regulatory compliance without compromising the process versatility of a dynamic urban water laboratory.

STARLIMS Corporation
Presidential Building 4000 Hollywood Blvd., Suite 515 South
Hollywood, FL, 33021-6755

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